11:21 AM EDT, 04/30/2024 (MT Newswires) -- Eton Pharmaceuticals ( ETON ) said Tuesday it submitted a new drug application to the US Food and Drug Administration seeking approval for ET-400, the company's patented formulation of hydrocortisone oral solution.

The drug maker said it expects a 10-month review from the FDA, with potential approval and launch in Q1 of 2025.

Eton also said it expects ET-400 and Alkindi Sprinkle, a replacement therapy in pediatric patients with adrenocortical insufficiency, to generate combined peak sales of over $50 million annually.

Eton holds a patent for ET-400 from the US Patent Office until 2043, with further patent applications under review, it said.

Shares of Eton were up more than 5% in recent trading.

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